CLASS III Drug recall · Reported 12 Oct 2016 · FDA Enforcement Report
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg recalled by Shire
Shire is recalling Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, distributed nationwide in the US. The recall was initiated on 2 Sep 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0006-2017
- FDA event ID
- 75170
- Recalling firm
- Shire, Chesterbrook, PA
- Brand
- Vyvanse
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Sep 2016
- FDA classified
- 5 Oct 2016
- Reported
- 12 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 2 Sep 2016 | Recall initiated by company | |
| 5 Oct 2016 | Classified by FDA | +33 days |
| 12 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot # AF3360B; Exp. 04/19
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Shire
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|---|---|---|---|---|---|
| Drug | CLASS II | Kalbitor (ecallantide), 10mg/mL recalled by ShireKalbitor | Shire | Particulate Matter | Nationwide |
| Drug | CLASS III | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa | Shire | Other | Nationwide |
Other Lisdexamfetamine Dimesylate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |